Trial · NCT00083889
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
NCT00083889, Phase 3, Completed, Pfizer; results first posted 2009-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma. Trials, record NCT00083889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00083889
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
- NCT number
- NCT00083889
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 750 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Interferon-alfa, SU011248
- First posted
- 2004-06-04
- Last updated
- 2010-01-26
- Results first posted
- 2009-12-10
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS), Core Radiology Assessment | Day 28 of each 6-week cycle: duration of treatment phase | Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods. |
| Primary | Progression-Free Survival (PFS), Investigator's Assessment | Day 28 of each 6-week cycle: duration of treatment phase | Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods. |
| Secondary | Objective Response, Core Radiology Assessment | Day 28 of each 6-week cycle: duration of treatment phase | Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR or PR) = those that persisted on repeat imaging study \>= 4 weeks after initial documentation of response. |
| Secondary | Objective Response, Investigator's Assessment | Day 28 of each 6-week cycle: duration of treatment phase | Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study \>= 4 weeks after initial documentation of response. |
| Secondary | Overall Survival (OS) | Clinic visit or telephone contact every 2 months until death | Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day. |
| Secondary | Time to Tumor Progression (TTP), Core Radiology Assessment | Randomization to first documentation of tumor progression: duration of treatment phase | TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day. |
| Secondary | Time to Tumor Progression (TTP), Investigator's Assessment | Randomization to first documentation of tumor progression: duration of treatment phase | TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day. |
| Secondary | Duration of Response (DR), Core Radiology Assessement | Day 28 of each cycle: duraton of treatment phase | Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression. |
| Secondary | Duration of Response (DR), Investigator's Assessment | Day 28 of each cycle: duration of treatment phase | Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression. |
| Secondary | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS), Core Radiology Assessment | Day 28 of each 6-week cycle: duration of treatment phase | Intent to treat (ITT) population: all patients who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | weeks | MEDIAN |
| SECONDARY | Objective Response, Core Radiology Assessment | Day 28 of each 6-week cycle: duration of treatment phase | ITT | participants | NUMBER |
| SECONDARY | Objective Response, Investigator's Assessment | Day 28 of each 6-week cycle: duration of treatment phase | ITT | participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Clinic visit or telephone contact every 2 months until death | ITT | weeks | MEDIAN |
| SECONDARY | Time to Tumor Progression (TTP), Core Radiology Assessment | Randomization to first documentation of tumor progression: duration of treatment phase | ITT | weeks | MEDIAN |
| SECONDARY | Time to Tumor Progression (TTP), Investigator's Assessment | Randomization to first documentation of tumor progression: duration of treatment phase | ITT | weeks | MEDIAN |
| SECONDARY | Duration of Response (DR), Core Radiology Assessement | Day 28 of each cycle: duraton of treatment phase | ITT | weeks | MEDIAN |
| SECONDARY | Duration of Response (DR), Investigator's Assessment | Day 28 of each cycle: duration of treatment phase | ITT | weeks | MEDIAN |
| SECONDARY | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | ITT; summary of FKSI-DRS questionnaire results by treatment; N=number of subjects with evaluable data; n = number of subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively. | scores on scale | MEAN |
| SECONDARY | FACT-Kidney Symptom Index (FKSI) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation. | scores on scale | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group839
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS), Core Radiology Assessment | SU011248 | 48.3 | 95% Confidence Interval 46.4 to 58.3 | weeks | |
| Progression-Free Survival (PFS), Core Radiology Assessment | IFN-α | 22.1 | 95% Confidence Interval 17.1 to 24.0 | weeks | |
| Objective Response, Core Radiology Assessment | SU011248 | 145 | participants | ||
| Objective Response, Core Radiology Assessment | IFN-α | 29 | participants | ||
| Objective Response, Investigator's Assessment | SU011248 | 171 | participants | ||
| Objective Response, Investigator's Assessment | IFN-α | 45 | participants | ||
| Overall Survival (OS) | SU011248 | 114.6 | 95% Confidence Interval 100.1 to 142.9 | weeks | |
| Overall Survival (OS) | IFN-α | 94.9 | 95% Confidence Interval 77.7 to 117.0 | weeks | |
| Time to Tumor Progression (TTP), Core Radiology Assessment | SU011248 | 49.1 | 95% Confidence Interval 46.6 to 59.1 | weeks | |
| Time to Tumor Progression (TTP), Core Radiology Assessment | IFN-α | 22.4 | 95% Confidence Interval 21.9 to 31.3 | weeks |
1 to 10 of 839Source ClinicalTrials.gov
See all 839 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SU011248 | 375 | |
| Overall Study | STARTED | IFN-α | 375 | |
| Overall Study | Received Treatment | SU011248 | 375 | |
| Overall Study | Received Treatment | IFN-α | 360 | |
| Overall Study | COMPLETED | SU011248 | 0 | |
| Overall Study | COMPLETED | IFN-α | 0 | |
| Overall Study | NOT COMPLETED | SU011248 | 375 | |
| Overall Study | NOT COMPLETED | IFN-α | 375 |
Source ClinicalTrials.gov
Adverse events574
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | SU011248 | 75 | 375 | |
| other | Anaemia | Blood and lymphatic system disorders | IFN-α | 55 | 360 | |
| other | Leukopenia | Blood and lymphatic system disorders | SU011248 | 40 | 375 | |
| other | Leukopenia | Blood and lymphatic system disorders | IFN-α | 16 | 360 | |
| other | Lymphopenia | Blood and lymphatic system disorders | SU011248 | 19 | 375 | |
| other | Lymphopenia | Blood and lymphatic system disorders | IFN-α | 21 | 360 | |
| other | Neutropenia | Blood and lymphatic system disorders | SU011248 | 69 | 375 | |
| other | Neutropenia | Blood and lymphatic system disorders | IFN-α | 33 | 360 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | SU011248 | 69 | 375 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | IFN-α | 15 | 360 |
1 to 10 of 574Source ClinicalTrials.gov
See all 574 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SU011248 | ||
| Total, all-cause mortality | IFN-α | ||
| Total, other adverse events | SU011248 | 368 | 375 |
| Total, other adverse events | IFN-α | 344 | 360 |
| Total, serious adverse events | SU011248 | 170 | 375 |
| Total, serious adverse events | IFN-α | 93 | 360 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SU011248 vs IFN-α: Objective Response, Core Radiology Assessment | Trial comparisons |
| SU011248 vs IFN-α: Objective Response, Investigator's Assessment | Trial comparisons |
| SU011248 vs IFN-α: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00083889
GET https://conductscience.org/api/trials/v1/NCT00083889/registered?page=2